Methods | Six-week randomised, double-blind study. | |
Participants | In- and outpatients fulfilling DSM-III-R criteria for major depressive disorder or bipolar disorder (currently depressive), with a score of at least 17 on the HDRS-17. Age range: 18-70 years old. Exclusion criteria: previous use of fluoxetine or lofepramine prior entry to study or during present episode, use of psychoactive drugs (a part from short acting benzodiazepines within 7 days prior entry), use of MAOI within 14 days and depot neuroleptics within 6 months, ECT, serious suicide risk, pregnancy, lactation, absence of contraception, histrory of glaucoma, cardiovascular disease or urinary retention, significant other medical illness, history of severe allergies or multiple adverse drug reaction, concurrent use of diuretics |
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Interventions | Fluoxetine: 90 participants. Lofepramine : 93 participants. Fluoxetine dose: 20 mg/day. Lofepramine dose range: 140-210 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression, Montgomery and Asberg Scale for Depression | |
Notes | Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |